Numerous clinical trials evaluate methimazole across Early Phase 1 through Phase 4, focusing primarily on thyroid disorders—including Graves' disease, hyperthyroidism, toxic nodular goiter, and Graves' orbitopathy—and glioblastoma multiforme. Sponsored by academic medical centers, health systems, and pharmaceutical entities, these studies reflect recruitment statuses ranging from recruiting and completed to suspended, terminated, or unknown. Investigational approaches include adjunctive nutritional interventions in pediatric cohorts and combination metabolic therapies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06240455 | SUSPENDED | Graves Disease |
Worg Biotherapeutics Inc. |
2026-03-31 | PHASE2 |
| NCT07369063 | RECRUITING | Graves Disease; Graves' Disease; Hyperthyroidism |
Northwell Health |
2025-08-01 | PHASE2 |
| NCT06327828 | NOT_YET_RECRUITING | Graves Disease |
Medical University of Graz |
2024-09-01 | |
| NCT05607407 | SUSPENDED | Glioblastoma; Glioma |
Case Comprehensive Cancer Center |
2023-01-30 | PHASE2 |
| NCT06068179 | RECRUITING | Graves' Disease |
The First Affiliated Hospital of Xiamen University |
2023-10-16 | PHASE2; PHASE3 |
| NCT04946123 | COMPLETED | Hyperthyroidism |
Lo.Li.Pharma s.r.l |
2021-07-05 | |
| NCT04776993 | UNKNOWN | Graves' Orbitopathy |
University of Pisa |
2023-03-02 | PHASE3 |
| NCT05461820 | RECRUITING | Graves Disease; Relapse; Treatment; Drug Withdrawal |
The First Affiliated Hospital with Nanjing Medical University |
2018-05-01 | PHASE4 |
| NCT05017610 | WITHDRAWN | Recurrent Glioblastoma; Recurrent Gliosarcoma |
Emory University |
2021-10-20 | EARLY_PHASE1 |
| NCT05118542 | COMPLETED | Hyperthyroidism; Graves Disease; Atherosclerosis of Artery; Pathophysiology |
Indonesia University |
2019-01-01 | PHASE3 |
| NCT02654041 | TERMINATED | Glioblastoma Multiforme (GBM) |
Musli Thyropeutics Ltd. |
2016-03 | PHASE2 |
| NCT01458600 | COMPLETED | Graves´ Disease |
Mikael Lantz |
2006-09 | PHASE4 |
| NCT02727738 | COMPLETED | Graves' Disease |
University of Pisa |
2014-01 | |
| NCT01849861 | UNKNOWN | Healthy |
Universidade Federal do Rio de Janeiro |
2011-09 | PHASE4 |
| NCT01893450 | TERMINATED | Graves Ophthalmopathy |
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
2008-06 | |
| NCT01560299 | COMPLETED | Graves Disease |
Mashhad University of Medical Sciences |
2010-02 | |
| NCT01849861 | Unknown status | Healthy |
Universidade Federal do Rio de Janeiro|Conselho Nacional de Desenvolvimento Científico e Tecnológico |
2011-09 | Phase 4 |
| NCT00150124 | COMPLETED | Toxic Nodular Goitre; Graves' Disease |
Steen Bonnema |
2003-01 | PHASE4 |
| NCT00001421 | COMPLETED | Dermatomyositis; Polymyositis |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
1995-06 | PHASE2 |
| NCT00150111 | COMPLETED | Graves´ Disease; Thyroid Associated Ophthalmopathy |
Odense University Hospital |
2003-06 | PHASE1; PHASE2 |
| NCT00150137 | COMPLETED | Toxic Nodular Goitre; Graves Disease |
Odense University Hospital |
2003-01 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2025-05-08)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).